Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported May 19, 2021
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunctio…
St. Jude Medical, Cardian Rhythm Management Division recalled ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm As… - a critical-severity action.
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm As… was recalled by St. Jude Medical, Cardian Rhythm Management Division in May 19, 2021. Reason: Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacem…. Check the official notice for the remedy. Verify recall #Z-1531-2021 with the FDA Devices before acting.
The recall
St. Jude Medical, Cardian Rhythm Management Division issued this critical-severity FDA Devices recall-Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacem….
- Critical
- severity level
- Class I
- classification
- May 19, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1531-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1531-2021) was formally reported on May 19, 2021, with the manufacturer initiating the action on March 15, 2021. It is classified under Critical severity (Class I), with a current status of Ongoing. St. Jude Medical, Cardian Rhythm Management Division is listed as the recalling firm, operating out of Sylmar, CA. Federal records list the affected scope as 95,042 pacemakers [updated 03/20/2023].
The documented reason for this recall is: Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the… Distribution data in the federal record shows the product reached: Worldwide distribution: U.S (nationwide) to states including.: 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, …. 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
95,042 pacemakers [updated 03/20/2023]
Related Recalls
6
3 from same agency
Product description
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Reason for recall
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1531-2021 |
| Date reported | May 19, 2021 |
| Date initiated | March 15, 2021 |
| Recalling firm | St. Jude Medical, Cardian Rhythm Management Division |
| Firm location | Sylmar, CA |
| Affected scope | 95,042 pacemakers [updated 03/20/2023] |
| Distribution | Worldwide distribution: U.S (nationwide) to states including.: 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, Puerto Rico, SC, SD,… |
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-1531-2021) 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? ▼
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.. Recalled by St. Jude Medical, Cardian Rhythm Management Division. Units affected: 95,042 pacemakers [updated 03/20/2023].
Why was this product recalled? ▼
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 19, 2021. Severity: Critical. Recall number: Z-1531-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: U.S (nationwide) to states including.: 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, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.( countries): [806 Amendment - after March 2021 - updated 3/20/2023] Algeria, Angola, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Benin, Bolivia, Brazil, Bulgaria, Cameroon, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Korea, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Palestine, Panama, Paraguay, Peru Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Servia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1531-2021) 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.
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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 May 19, 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.