Abbott (formally known as “St. Jude Medical”) Recalls Assurity | 合法醫療器材資訊網

2021年5月13日—Abbott(formallyknownas“St.JudeMedical”)RecallsAssurity™andEndurity™PacemakersforPotentialMoistureIngressCausingElectricalShort ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product Scalable Bradycardia Platform (SBP) Pacemakers: Assurity™ and Endurity™ Distribution Dates: April 29, 2015 to February 20, 2019 Devices Recalled in the U.S.: 61,973 Date Initiated by Firm: March 15, 2021 Device Use

Assurity™ and Endurity™ are implantable pacemakers that detect when the heart is beating too slowly (bradycardia) and then send signals to the heart to make it beat at the correct pace. These pacemakers can be used to provide pacing for one chamber of the heart or both chambers, based on the patient’s condition.

Reason for Recall

Abbott (formally known as “St. Jude Medical”) is recalling a subset ...

Abbott recalls pacemakers that may short circuit | 合法醫療器材資訊網

Abbott (formally known as “St. Jude Medical”) Recalls Assurity | 合法醫療器材資訊網

2021年5月13日 — Abbott (formally known as “St. Jude Medical”) Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short ... Read More

2021 Medical Device Recalls | 合法醫療器材資訊網

Abbott (formally known as St. Jude Medical) Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced ... Read More

Product Advisories | 合法醫療器材資訊網

Safety Notification: Subset of Assurity and Endurity Pacemakers – March 15, 2021 ... A Safety Notification was issued for a subset of Assurity™ and Endurity™ ... Read More

FDA Recalls 60 | 合法醫療器材資訊網

2021年5月17日 — Abbott's SBP model pacemakers, sold under the Assurity and Endurity names, are being recalled because of the risk of electrical shorts. Read More

Recalls Assurity™ and Endurity™ Pacemakers for Potential ... | 合法醫療器材資訊網

2021年5月17日 — https://www.fda.gov/medical-devices/medical-device-recalls/abbott-formally-known-st-jude-medical- ... Date Initiated by Firm: March 15, 2021. Read More

Abbott Safety Notification Regarding a Subset of Assurity and ... | 合法醫療器材資訊網

2021年3月19日 — On March 15, 2021, Abbott announced a safety notification that some Assurity and Endurity pacemakers manufactured between 2015 and 2018 have ... Read More

Abbott Recalls Assurity and Endurity Pacemakers | 合法醫療器材資訊網

May 14, 2021 — Abbott is recalling a subset of Assurity and Endurity pacemakers built using specific manufacturing equipment distributed from April 2015 to ... Read More

Abbott recalls pacemakers that may short circuit | 合法醫療器材資訊網

2021年5月13日 — Abbott is recalling certain pacemakers that may short circuit because they can allow moisture inside, according to the FDA. Read More

FDA announces recall of more than 60 | 合法醫療器材資訊網

2021年5月14日 — The FDA has announced that Abbott is recalling more than 60,000 Assurity and Endurity implantable pacemakers due to a risk of moisture causing ... Read More

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