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Atrium Medical Corporation FDA Recalls
89 recalls on file across devices, 2 of them Class I and 88 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FClass IIAug 7, 2026An Out of Specification result (OOS) related to bacterial en |
| Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);Class IIAug 7, 2026An Out of Specification result (OOS) related to bacterial en |
| Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. Class IIAug 7, 2026An Out of Specification result (OOS) related to bacterial en |
| iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616Class IISep 9, 2024There is an error in the Unique Device Identifier (UDI) prin |
| FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass IIMay 3, 2024Complaints of reported separation of the Slider GDS Swivel R |
| Atrium Oasis Drain Single W / AC, Part No. 3600-100Class IINov 1, 2023A sterilization nonconformance prematurely aged the product |
| Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.Class IISep 29, 2023A sterilization nonconformance prematurely aged the product, |
| Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of Class IISep 21, 2023Balloon-to-catheter weld failure that may cause loss of ball |
| Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)Class IISep 18, 2023Instructions for Use (IFU) for the Atrium Ocean, Oasis, and |
| Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRUClass IISep 18, 2023Instructions for Use (IFU) for the Atrium Ocean, Oasis, and |
| Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDIClass IISep 18, 2023Instructions for Use (IFU) for the Atrium Ocean, Oasis, and |
| Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERYClass IISep 5, 2023Product was re-processed and re-sterilized by a third party |
| Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTIONClass IISep 5, 2023Product was re-processed and re-sterilized by a third party |
| Express Mini 500 Dry Seal Chest Drain, Part Number 16400Class IIMar 1, 2023The Instructions for Use (IFU) for the Pneumostat Chest Drai |
| Atrium Pneumostat Chest Drain Valve, Part Number 16100Class IIMar 1, 2023The Instructions for Use (IFU) for the Pneumostat Chest Drai |
| Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000Class IIOct 18, 2022Warehouse experienced temperature excursions in July and Aug |
| Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest caviClass IIApr 21, 2022Mismatch between the expiration date on the sterile barrier |
| Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85Class IMar 3, 2022Firm has observed increased rate of customer complaints rela |
| iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 Class IMar 3, 2022Firm has observed increased rate of customer complaints rela |
| The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chambeClass IIOct 22, 2021Inadequate/inappropriate Set-Up Instructions, which may resu |
| Atrium Pneumostat Chest Drain Valve, Part Number 16100Class IIAug 26, 2021The firm is revising the Indication for Use, Contraindicatio |
| Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascClass IIAug 25, 2021The product package may potentially contain a mismatched gra |