Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported May 24, 2023
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abiomed, Inc. recalled Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that sup… - a critical-severity action.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that sup… was recalled by Abiomed, Inc. in May 24, 2023. Reason: The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.. Check the official notice for the remedy. Verify recall #Z-1590-2023 with the FDA Devices before acting.
The recall
Abiomed, Inc. issued this critical-severity FDA Devices recall-The Impella 5.5 pump experienced a heightened complaint rate for purge leaks..
- Critical
- severity level
- 610 units
- affected scope
- Class I
- classification
- May 24, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1590-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1590-2023) was formally reported on May 24, 2023, with the manufacturer initiating the action on April 17, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Abiomed, Inc. is listed as the recalling firm, operating out of Danvers, MA. Federal records list the affected scope as 610 units.
The documented reason for this recall is: The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. Distribution data in the federal record shows the product reached: US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany. 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
610 units
Related Recalls
6
3 from same agency
Product description
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
Reason for recall
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1590-2023 |
| Date reported | May 24, 2023 |
| Date initiated | April 17, 2023 |
| Recalling firm | Abiomed, Inc. |
| Firm location | Danvers, MA |
| Affected scope | 610 units |
| Distribution | US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany |
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-1590-2023) 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? ▼
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US). Recalled by Abiomed, Inc.. Units affected: 610 units.
Why was this product recalled? ▼
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2023. Severity: Critical. Recall number: Z-1590-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1590-2023) 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.
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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 May 24, 2023. 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.