| Date Initiated by Firm |
June 17, 2022 |
| Create Date |
August 02, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1496-2022 |
| Recall Event ID |
90530 |
| PMA Number |
P880086 P140033 P030035 |
| Product Classification |
implantable pacemaker Pulse-generator - Product Code DXY
|
| Product |
Merlin 2 PCS MER37000 programmer Model MER3400 software |
| Code Information |
Software Model MER3400 v1.1.2 rev 1 or earlier.; UDI/DI 05415067037121 |
Recalling Firm/
Manufacturer |
St. Jude Medical, Cardiac Rhythm Management Division
15900 Valley View Ct
Sylmar CA 91342-3577
|
| For Additional Information Contact |
Ms. Alicia Swanson
408-845-3427
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
Software design |
| Action |
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. |
| Quantity in Commerce |
622 programs |
| 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
|
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| PMA Database |
PMAs with Product Code = DXY and Original Applicant = Abbott Medical
|
