Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 2, 2017
CS 300 Intra-Aortic Balloon Pump
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Maquet Datascope Corp - Cardiac Assist Division recalled CS 300 Intra-Aortic Balloon Pump - a critical-severity action.
CS 300 Intra-Aortic Balloon Pump was recalled by Maquet Datascope Corp - Cardiac Assist Division in August 2, 2017. Reason: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance c…. Check the official notice for the remedy. Verify recall #Z-2738-2017 with the FDA Devices before acting.
The recall
Maquet Datascope Corp - Cardiac Assist Division issued this critical-severity FDA Devices recall-The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance c….
- Critical
- severity level
- 12K units
- affected scope
- Class I
- classification
- August 2, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2738-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2738-2017) was formally reported on August 2, 2017, with the manufacturer initiating the action on June 16, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Maquet Datascope Corp - Cardiac Assist Division is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 12,319 units total.
The documented reason for this recall is: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device … Distribution data in the federal record shows the product reached: Worldwide Distribution - (in over 100 countries) US (Nationwide). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
12,319 units total
Related Recalls
6
3 from same agency
Product description
CS 300 Intra-Aortic Balloon Pump
Reason for recall
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2738-2017 |
| Date reported | August 2, 2017 |
| Date initiated | June 16, 2017 |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division |
| Firm location | Mahwah, NJ |
| Affected scope | 12,319 units total |
| Distribution | Worldwide Distribution - (in over 100 countries) US (Nationwide) |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2738-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CS 300 Intra-Aortic Balloon Pump. Recalled by Maquet Datascope Corp - Cardiac Assist Division. Units affected: 12,319 units total.
Why was this product recalled? ▼
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2017. Severity: Critical. Recall number: Z-2738-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - (in over 100 countries) US (Nationwide).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2738-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 2, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.