Device product

MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

Z-1685-2022

August 05, 2022

Class II

Product summary

Firm: Datascope Corporation
Event: Event 90684
Status: Ongoing
Classification: Class II
Quantity: 10,427 units
Official record key: device-enforcement:Z-1685-2022

Official wording

Reason: Certain lots containing undersized dilator.

Code information: Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01.

Distribution pattern: Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Certain lots containing undersized dilator.