Overview of recall records associated with Atrium Medical Corporation, including dates, categories and classifications where available.
Classification mix: Class II: 111, Class I: 2.
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube…
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube…
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube…
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for…
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for…
Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024…
Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural…
Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural…
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect…
An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside…
Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x…
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Outer Packaging is not sterile
Outer Packaging is not sterile
This page summarizes recall records in which the official source identifies Atrium Medical Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
