Health Canada — Medical Devices · Canada · 2022-04-04 · Type II
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Reported risk: During a routine inspection Medtronic noted there was damage to the sterile pouch that contains the In.Pact Admiral Catheters. Upon investigation, 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. Damage to the pouch can cause a loss of sterility and may result in potential clinical harm of systemic reaction including infection. The affected units are limited to specific lot numbers of In.Pact Admiral Catheters. No other Medtronic products are affected by this issue. Through 11-March-2022, Medtronic has received no (0) complaints involving this issue. There are no actions required for patients where the affected In.Pact Admiral Catheters were used during a procedure. These patients should continue to be monitored in accordance with the medical facility's standard care protocols. Recall start date: Mar 25, 2022
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