Medtronic’s list of recalls this year continues to grow. The Dublin-based company said it is recalling some of the In.Pact Admiral and In.Pact AV Paclitaxel-coated Percutaneous Transluminal Angioplasty balloon catheters because of manufacturing issues.
Medtronic said the production line issues has since been corrected. About 6,000 IN.PACT Admiral catheters and 3 IN.PACT AV catheters were impacted.
Medtronic said the pouch damage was discovered during a routine inspection. Upon investigation, a change implemented to one manufacturing line was determined to be the cause. All batches manufactured on this line after that change are being retrieved. The problem on that line was fixed. Additionally, to ensure that no further issues, production on all lines was paused until a follow up packaging inspection was completed.
The company said no further errors were discovered.
Medtronic noted that it hasn't received any complaints involving this issue. The firm said there weren't any reports of injury or death related to this issue and noted there are no actions required for patients where the affected IN.Pact Admiral and IN.Pact AV catheters were used during a procedure. Patients should continue to be monitored in accordance with the medical facility’s standard care protocols, Medtronic said.
The medtech giant kicked off 2022 by recalling its Synergy Cranial and StealthStation S7 Cranial software due to the risk of potential inaccuracies caused by the Biopsy Depth Gauge Cycle View.
Shortly after, the company said announced recalling the HawkOne Directional Atherectomy System, is used during procedures to clear blocked peripheral arteries and improve blood flow. The firm initiated the recall due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use.
Medtronic closed out 2021 with a recall. FDA rated the recall of Medtronic’s Puritan Bennett Continuous ventilators a Class I, the most serious rating. The issue stemmed from an error in the technology’s manufacturing assembly in which a capacitor in the ventilators is incorrectly assembled, potentially causing the devices to stop working mid-use.