Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
Atrium Medical Corporation is recalling specific lots of Getinge PVC Thoracic Catheters because an out-of-specification result was found in bacterial endotoxin testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves bacterial endotoxins in an invasive medical device, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Atrium Medical Corporation is voluntarily recalling specific lots of Getinge PVC Thoracic Catheters, Soft PVC Straight. The recall involves 3,618 units distributed nationwide in the United States. The affected products are identified by specific model numbers and lot numbers, including 16FR (Lot ME244878), 24FR (Lot ME244835), 28FR (Lots ME244682, ME244836, ME244837, ME244681), 32FR (Lot ME244840), and 36FR (Lot ME244686).
The recall was initiated due to an out-of-specification (OOS) result related to bacterial endotoxin testing in a single lot of catheters. Bacterial endotoxins are substances that can cause adverse health effects if introduced into the body, particularly in invasive medical devices.
Healthcare providers and facilities should check their inventory for the specific lot numbers and model numbers listed above. If these products are found, they should be removed from use and returned to Atrium Medical Corporation or the distributor as directed by the company. Patients who have had these catheters implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 3,618
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 1. Model Number(Size): 8016(16FR)
- UDI-DI: 00650862130164
- Lot Number: ME244878
- 2. Model Number(Size): 8024(24FR)
- UDI-DI: 00650862130249
- Lot Number: ME244835
- 3. Model Number(Size): 8028(28FR)
- UDI-DI: 00650862130287
- Lot Numbers: ME244682
- ME244836
- ME244837
- ME244681
- 4. Model Number(Size): 8032(32FR)
- UDI-DI: 00650862130324
- Lot Number: ME244840
- 5. Model Number(Size): 8036(36FR)
- UDI-DI: 00650862130362
- Lot Number: ME244686
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Atrium Medical Corporation
See all →- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- ModerateiCast Covered Stent Recalled for Unique Device Identifier Labeling Error
FDA (Devices) · 2024-10-16
- HighVascular graft devices recalled due to slider component separation
FDA (Devices) · 2024-06-12
- HighVascular graft component separation reported in Advanta VXT devices
FDA (Devices) · 2024-06-12
Same hazard · bacterial endotoxin
See all →- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels
FDA (Devices) · 2025-04-02
- HighShoulder implant recalled due to excessive bacterial endotoxin
FDA (Devices) · 2024-09-25
- HighEchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin
FDA (Devices) · 2024-05-22