Safety Alerts

Medical device manufacturer, Medtronic, Inc., issued a medical device safety alert concerning IN.PACT Admiral and IN.PACT AV Paclitaxel-coated PTA Balloon Catheters [CFN: SBI06015013P; Lot Serial: 0010745656] [HKMD No.: 100030].

The manufacturer is voluntarily recalling a subset of IN.PACT Admiral and IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheters due to the potential for pouch damage resulting in potential loss of sterility.

According to the manufacturer, during a routine inspection, there was damage to the sterile pouch that contains the IN.PACT Admiral or IN.PACT AV catheter. An investigation determined that there had been a change implemented to one manufacturing line which may cause pouch damage. All batches manufactured on this line after that change are being retrieved.

The affected units are limited to the lot numbers of IN.PACT Admiral and IN.PACT AV catheters listed above. No other Medtronic products are affected by this issue. Damage to the pouch can cause a loss of sterility and may result in potential clinical harm of systemic reaction including infection. Through 11 MAR 2022, the manufacturer has received zero (0) complaints or reports of patient injury related to this issue.

Actions:

• Identify and quarantine all unused affected IN.PACT Admiral and IN.PACT AV catheters as listed above.
• Return all unused affected product in the inventory to Medtronic. Contact Medtronic Field Representatives to initiate a product return.

According to the local supplier, the affected devices are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 23 Mar 2022