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Thoratec Corp. recall records

8 reported ongoing

8 records in this archive. Latest source date May 8, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device

System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenie...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, BULGARIA, SWITZERLAND, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, EG...

Official source
FDA device enforcement

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

Class IReported ongoing

Distribution: Worldwide Distribution: US (nationwide): 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, ...

Official source
FDA device enforcement

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

Class IReported ongoing

Distribution: Worldwide Distribution: US (nationwide): 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, ...

Official source
FDA device enforcement

HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate...

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

Class IReported ongoing

Distribution: Worldwide distribution: U.S.(nationwide): 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, ...

Official source
FDA device enforcement

HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Gra...

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

Class IReported ongoing

Distribution: Worldwide distribution: U.S.(nationwide): 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, ...

Official source
FDA device enforcement

1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate...

Due to software and controller systems that results in unexpected pump start or pump stop.

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Z...

Official source
FDA device enforcement

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 extended procedure or surgical time while the backup coring knife is acquired.

Class IIReported ongoing

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,...

Official source
FDA device enforcement

Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, IL, PA, AR, GA, WI, AZ, TN, TX, MA, NE, CA, VA, NC, OH, MI, DC, IN, NJ, CT, OK, MD, NY, ME, IA, SC, KY, ...

Official source

Reasons in these listed records

  • System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic com...
  • Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
  • Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
  • Due to software and controller systems that results in unexpected pump start or pump stop.

These examples come from this result page and are not a ranking of every recall reason.

Checking Thoratec Corp.

Is there a recall on thoratec corp. right now?

This archive contains 8 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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