Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported February 10, 2021
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum numbe…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Heartware, Inc. recalled Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 11… - a critical-severity action.
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 11… was recalled by Heartware, Inc. in February 10, 2021. Reason: Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start…. Check the official notice for the remedy. Verify recall #Z-0946-2021 with the FDA Devices before acting.
The recall
Heartware, Inc. issued this critical-severity FDA Devices recall-Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start….
- Critical
- severity level
- 20K units
- affected scope
- Class I
- classification
- February 10, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0946-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0946-2021) was formally reported on February 10, 2021, with the manufacturer initiating the action on November 19, 2020. It is classified under Critical severity (Class I), with a current status of Ongoing. Heartware, Inc. is listed as the recalling firm, operating out of Miami Lakes, FL. Federal records list the affected scope as 19,562 units.
The documented reason for this recall is: Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substant… Distribution data in the federal record shows the product reached: Worldwide - 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
19,562 units
Related Recalls
6
3 from same agency
Product description
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
Reason for recall
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0946-2021 |
| Date reported | February 10, 2021 |
| Date initiated | November 19, 2020 |
| Recalling firm | Heartware, Inc. |
| Firm location | Miami Lakes, FL |
| Affected scope | 19,562 units |
| Distribution | Worldwide - 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-0946-2021) 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? ▼
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU. Recalled by Heartware, Inc.. Units affected: 19,562 units.
Why was this product recalled? ▼
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Critical. Recall number: Z-0946-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0946-2021) 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 February 10, 2021. 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.