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Merlin recallZ-1495-2022 · St. Jude Medical, Cardiac Rhythm Management Division · initiated Jun 17, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from St. Jude Medical, Cardiac Rhythm Management Division or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.

FDA root cause category: Software design

What the company is doing

On June 16, 2022 Abbott issued a "Medical Device Correction" via: XXXX to affected consignees. The customer notification ask consignees to take the following action: 1. Prophylactic device replacement is not recommended, as device functionality, actual longevity, and ERI indicator are not impacted (device functionality remains normal and within specifications). 2. Routine follow-up should remain as per local standard of care and clinical protocol, and ERI should continue to serve as an indicator of the need for device replacement scheduling. 3. Please direct any questions about device longevity to Abbott Technical Support at 1-800-722-3774 (U.S.). 4.Upon programmer software / remote monitoring software update, the improved longevity estimate will be displayed at the patient s next interrogation. Please note that until programmers are updated, a difference in longevity estimates between programmers and remote monitoring (Merlin.net) may be observed.

Recall details

Recall number
Z-1495-2022
Status
Open, Classified
Initiated by the company
Jun 17, 2022
Recalling firm
St. Jude Medical, Cardiac Rhythm Management Division
Quantity
29,996 programs
Product code
DXY
FDA submissions
P880086, P140033, P030035
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. BRAZIL BULGARIA Burnei Cambodia CAMEROON Canada Chile China Colombia COTE D'IVOIRE CUBA CYPRUS CZECH REPUBLIC DENMARK DOMINICAN REP. ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FAROE ISLANDS FINLAND FRANCE GEORGIA GERMANY GREECE GREENLAND GUATEMALA Hong Kong HUNGARY ICELAND India Indonesia IRELAND ISRAEL ITALY JORDAN KAZAKHSTAN KOSOVO KUWAIT KYRGYZSTAN LATVIA LEBANON LIBYA LIECHTENSTEIN LITHUANIA LUXEMBOURG MACEDONIA Malaysia MALTA MAURITIUS Mexico MONGOLIA MONTENEGRO MOROCCO Myanmar Nepal NETHERLANDS New Zealand NORWAY OMAN Pakistan PALESTINE PANAMA PARAGUAY PERU Philippines POLAND PORTUGAL QATAR ROMANIA RUSSIAN FED. SAUDI ARABIA SENEGAL Singapore SLOVAKIA SLOVENIA SOUTH AFRICA South Korea SPAIN Srilanka SUDAN SWEDEN SWITZERLAND Taiwan Thailand TRINIDAD TUNISIA TURKEY UKRAINE United Arab Emirates UNITED KINGDOM UZBEKISTAN VENEZUELA Vietnam VIRGIN ISLAND YEMEN ZAMBIA

Product description

Merlin PCS 3650 programmer Model 3330 software

Code information (models, lots, serial numbers)

Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

55 devices cleared under P880086, P140033, P030035 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 90530).

Sources and updates

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