Sylmar, CA, United States
St. Jude Medical, Cardiac Rhythm Management Division recalls
5 recalls recorded since 2018, most recently on 17 June 2022. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)3
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 June 2022
- Reason
- The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
- Distribution
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VI VT WA WI WV WY , Guam OUS: ALBANIA ALGERIA ANGOLA Argentina ARMENIA Australia AUSTRIA AZERBAIJAN BAHRAIN Bangladesh BELGIUM BENIN BOLIVIA BOSNIA-HERZ.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1496-2022, Z-1495-2022, Z-1497-2022
- Merlin 2 PCS MER37000 programmer Model MER3400 software
- Merlin PCS 3650 programmer Model 3330 software
- Merlin.net model MN5000 Software
Ongoing Class II Medical devices
- Recall started
- 10 March 2022
- Reason
- Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0990-2022, Z-0988-2022, Z-0989-2022
- Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
- Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
- Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Ongoing Class II Medical devices
- Recall started
- 10 March 2022
- Reason
- Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY. The countries of Argentina
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0965-2022, Z-0964-2022
- Merlin 2 PCS MER3700 programmer Model MER3400 software
- Merlin PCS 3650 programmer Model 3330 software
Terminated Class II Medical devices
- Recall started
- 22 January 2020
- Terminated
- 17 December 2020
- Reason
- Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
- Distribution
- U.S.: WV, MS, TX, DE, OH, AZ, MI, NC, KY, WA, NY, CA, IN, MO, MD, NJ, FL, PA, OK. O.U.S.: United Kingdom, Turkey, Sweden, Spain, Portugal, Poland, Philippines, Pakistan, Norway, New Zealand, Netherlands, Japan, Italy, Hong Kong, Greece, Germany, France, Finland, Denmark, Canada, Belgium, Austria,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1351-2020
- Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-
Terminated Class II Medical devices
- Recall started
- 13 April 2018
- Terminated
- 10 February 2021
- Reason
- Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
- Distribution
- Worldwide distribution - US Nationwide. distribution. There was also government/military distribution. Countries of Canada, Aruba, Australia, Belgium, Brazil, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jo
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0808-2020
- Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylm
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.