The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0091-2022·Announced 2021-10-27

Cardiosave Li-Ion battery pack recalled for insufficient runtime specification

Datascope Corp. is recalling Cardiosave Li-Ion battery packs that failed to meet minimum runtime requirements. These nonconforming batteries were inadvertently released to customers worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recalls require a minimum severity score of 4 per the rubric. The defect involves critical-care medical devices where battery runtime failure could result in device malfunction during patient treatment. No patient injuries or deaths have been reported.

Plain-English summary

Datascope Corp. is recalling Cardiosave Li-Ion Battery Packs (Part No. 0146-00-0097), which are components of the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs). These devices provide cardiac support during critical medical procedures.

During protocol testing, some battery packs failed to meet the minimum runtime requirement specified by Getinge (the product's internal specification). These nonconforming batteries were inadvertently released to customers instead of being rejected as defective.

Approximately 131 battery packs and 11,517 pumps were affected. The products have been distributed worldwide, including to the United States, Australia, Brazil, Bahrain, Belgium, Canada, China, Czech Republic, Egypt, France, Germany, India, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, Pakistan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, United Arab Emirates, Philippines, and Russia.

Patients and healthcare providers using affected Cardiosave pumps should contact Datascope Corp. for information about battery replacement or device status verification. Specific battery serial numbers are available to identify affected units.

The recalled product

Product
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36…
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Equipment
Hazard

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 (20)

  • Battery Pack Serial Numbers: 192224349IP
  • 191908720IP
  • 202369811IP
  • 202791944IP
  • 191848115IP
  • 192099841IP
  • 192103741IP
  • 192104141IP
  • 171218521PE
  • 181642339PE
  • 202321308IP
  • 191912520IP
  • 191874716IP
  • 191922620IP
  • 181642639PE
  • 192185446IP
  • 171277935PE
  • 192190247IP
  • 202400219IP
  • 202323808IP

Distribution

Distributed nationwide across the United States.

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