Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported January 22, 2025
Impella RP Flex with SmartAssist; Product Number: 1000323;
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Ve…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abiomed, Inc. recalled Impella RP Flex with SmartAssist; Product Number: 1000323; - a critical-severity action.
Impella RP Flex with SmartAssist; Product Number: 1000323; was recalled by Abiomed, Inc. in January 22, 2025. Reason: Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting …. Check the official notice for the remedy. Verify recall #Z-0830-2025 with the FDA Devices before acting.
The recall
Abiomed, Inc. issued this critical-severity FDA Devices recall-Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting ….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- January 22, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0830-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0830-2025) was formally reported on January 22, 2025, with the manufacturer initiating the action on December 12, 2024. 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 2,364 units.
The documented reason for this recall is: Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Ar… Distribution data in the federal record shows the product reached: Domestic: Nationwide Distribution International: Canada. 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
2,364 units
Related Recalls
6
3 from same agency
Product description
Impella RP Flex with SmartAssist; Product Number: 1000323;
Reason for recall
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0830-2025 |
| Date reported | January 22, 2025 |
| Date initiated | December 12, 2024 |
| Recalling firm | Abiomed, Inc. |
| Firm location | Danvers, MA |
| Affected scope | 2,364 units |
| Distribution | Domestic: Nationwide Distribution International: Canada |
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-0830-2025) 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 RP Flex with SmartAssist; Product Number: 1000323;. Recalled by Abiomed, Inc.. Units affected: 2,364 units.
Why was this product recalled? ▼
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Critical. Recall number: Z-0830-2025.
Where was the recalled product distributed? ▼
Distribution: Domestic: Nationwide Distribution International: Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0830-2025) 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.
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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 January 22, 2025. 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.