The Recall Desk
SevereFDA (Devices)·Z-2432-2023·Announced 2023-09-06

Cardiosave Rescue Intra-Aortic Balloon Pumps Fail to Charge When Improperly Inserted

Datascope Corp. is recalling 9,175 units of Cardiosave Rescue IABP devices because batteries will not charge if the console is not fully inserted into the hospital cart. Users were often unaware of this insertion requirement.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this as a Class I recall, which per the rubric requires a minimum severity score of 4. The device is critical-care medical equipment; failure to charge could result in device malfunction during patient use.

Plain-English summary

Datascope Corp. is recalling 9,175 units of Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. These critical-care devices were distributed worldwide, including nationwide in the United States.

Users reported that the device was not charging as expected. FDA investigation determined that the battery will not charge when the console is not completely inserted into the hospital cart. The root cause is that many users were unaware of this insertion requirement.

Healthcare facilities and clinical staff using these devices should verify that the Cardiosave console is fully inserted into the cart before relying on battery operation. Proper insertion is required for the charging mechanism to function.

The recalled product

Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Equipment
Hazard
Affected units
9,175

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • All Lot Numbers. Model: 0998-00-0800-75
  • UDI: 10607567112312
  • Model: 0998-00-0800-83
  • UDI: 10607567108407
  • Model: 0998-00-0800-85
  • UDI: 10607567113449

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Datascope Corp.

See all →

Same hazard · charging failure

See all →