Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 11, 2023
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an ex…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Thoratec Corp. recalled Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apic… - a moderate-severity action.
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apic… was recalled by Thoratec Corp. in October 11, 2023. Reason: Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knif…. Check the official notice for the remedy. Verify recall #Z-2658-2023 with the FDA Devices before acting.
The recall
Thoratec Corp. issued this moderate-severity FDA Devices recall-Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knif….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- October 11, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2658-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2658-2023) was formally reported on October 11, 2023, with the manufacturer initiating the action on August 7, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Thoratec Corp. is listed as the recalling firm, operating out of Pleasanton, CA. Federal records list the affected scope as 2,681.
The documented reason for this recall is: Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while … Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, W…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,681
Related Recalls
6
3 from same agency
Product description
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Reason for recall
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2658-2023 |
| Date reported | October 11, 2023 |
| Date initiated | August 7, 2023 |
| Recalling firm | Thoratec Corp. |
| Firm location | Pleasanton, CA |
| Affected scope | 2,681 |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the co… |
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-2658-2023) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050. Recalled by Thoratec Corp.. Units affected: 2,681.
Why was this product recalled? ▼
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2658-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia , Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2658-2023) 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 October 11, 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.