Datascope Corporation: Medical Device Recall in 2022 - (Recall #: Z-1685-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

Product Classification:

Class II

Date Initiated: August 5, 2022

Date Posted: September 14, 2022

Recall Number: Z-1685-2022

Event ID: 90684

Reason for Recall:

Certain lots containing undersized dilator.

Status: Ongoing

Product Quantity: 10,427 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated