Lower risk Medical device recall · FDA · Published October 3, 2019

Datascope Low Level Output Cable Recall: Incorrect Cable in Packaging

Datascope recalls a specific low level output cable for cardiac pumps due to incorrect cable in packaging. Affected units may have safety risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0266-2020Medical device Datascope ›

Lower-risk recall

One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.

Take action

Contact the company

Recalling firmDatascope Corp.1300 Macarthur Blvd · Mahwah, NJ 07430-2052

✎ GovInfoNow plain-language explainer

Datascope is recalling a low level output cable used with certain cardiac pumps because it was shipped with the wrong cable. This could lead to improper function of the medical device. Read more at govinfonow.com/recall/66908-datascope-low-level-output-cable-recall-incorrect-cable-in-packaging.

Source Summary by GovInfoNow · govinfonow.com/recall/66908-datascope-low-level-output-cable-recall-incorrect-cable-in-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0266-2020

Cite this page

“Datascope Low Level Output Cable Recall: Incorrect Cable in Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66908-datascope-low-level-output-cable-recall-incorrect-cable-in-packaging. Based on FDA recall #Z-0266-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0266-2020%22&limit=1).

The FDA announced on 2019-10-03 that Datascope Corp. voluntarily recalled Low Level Output Cable Interface to Philips Monitor for use with Cardiosave and CS300 Intra-Aortic Balloon Pumps. The hazard involves one lot containing an incorrect cable in the packaging.

How to tell if you have it

Datascope
Low Level Output Cable - Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps
Part Number 0012-00-1589-03
10000493876

The hazard

One lot of the Low Level Output Cable was received from the supplier with an incorrect cable in the packaging.

Context

GovInfoNow's records show Datascope Corp. has had 29 other recalls since 2019-06-17, including a 2026-02-06 recall for a Battery Charging Station due to a protruding screw and a 2026-01-23 software update for the CS300 IABP. Other recent recalls of similar products include Maquet Bubble Sensor Recall (2026-01-09) and Beaver-Visitec OME6000U Laser System Recall (2025-12-05).

How to tell if you have this one

Check for the part number 0012-00-1589-03 on the cable packaging. The cable is used with Cardiosave and CS300 intra-aortic balloon pumps.

Brand
Datascope
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Cable Packaging
Look for the part number 0012-00-1589-03 on the cable packaging to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “Distributed to CA, GA, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Georgia, Texas.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Oct 3, 2019Firm started the recall
Nov 1, 2019FDA classified it Class II
Nov 13, 2019Published in FDA’s Enforcement Report
Jan 8, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Datascope recalls

Link to this recall

<a href="https://govinfonow.com/recall/66908-datascope-low-level-output-cable-recall-incorrect-cable-in-packaging">Datascope Low Level Output Cable Recall: Incorrect Cable in Packaging (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0266-2020 (October 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0266-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.