BlueSky TPM020URecalls & reported problems
Microport Crm Srl · BlueSky DR Alizea 1600 · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08031527018997), received between Jan 17, 2025 and Jan 17, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unexpected Mode Switch” (2 reports).
1 other recall cover devices cleared under the same FDA submission (P950029); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unexpected Mode Switch2
- Premature Discharge of Battery1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2025Premature Discharge of Battery; Unexpected Mode Switch; Premature Discharge of Battery; Unexpected Mode Switch
ON (B)(6), DURING AN IN-CLINIC INTERROGATION OF ALIZEA DR (B)(6), A WARNING MESSAGE STATING "RRT OCCURRED ON (B)(6) 2024. MAGNET RATE 80" IS DISPLAYED. THE DEVICE IS FOUND PROGRAMMED IN VVI MODE AND IS DISPLAYING THE CURRENT BATTERY VOLTAGE VALUE TO BE 3.12V.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179847 ↗InjuryJan 17, 2025Unexpected Mode Switch; Unexpected Mode Switch
ON DECEMBER 19, 2024, MICROPORT CRM REP (B)(6) CALLED TECHNICAL SERVICES STATING THAT HE WAS PERFORMING AN IN-CLINIC INTERROGATION OF (B)(6). UPON INTERROGATION, A WARNING MESSAGE STATING "RRT OCCURRED ON (B)(6) 2024. MAGNET RATE 80" IS DISPLAYED. (B)(6) STATES THE DEVICE IS FOUND PROGRAMMED IN VVI MODE AND IS DISPLAYING THE CURRENT BATTERY VOLTAGE VALUE TO BE 3.12V.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179596 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P950029. One submission often covers many models, so check the product and lot details in each record.
- Z-2235-2009 · Sep 23, 2008 · TerminatedSorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14
Other Implantable Pacemaker Pulse-Generator devices
- CareLink Encore™ 29901Medtronic, Inc. · implantable pacemaker Pulse-generator3 recalls265 reports
- Victory™ 5816St. Jude Medical, Inc. · implantable pacemaker Pulse-generator5 deaths347 reports
- Identity™ 5386St. Jude Medical, Inc. · implantable pacemaker Pulse-generator3 deaths154 reports
- Verity™ ADx XL DRSt. Jude Medical, Inc. · implantable pacemaker Pulse-generator100 reports
- Verity™ ADx XL VDRSt. Jude Medical, Inc. · implantable pacemaker Pulse-generator59 reports
- Identity™ 5286St. Jude Medical, Inc. · implantable pacemaker Pulse-generator53 reports
- NA 6725Medtronic, Inc. · implantable pacemaker Pulse-generator1 death39 reports
- Identity™ 5376St. Jude Medical, Inc. · implantable pacemaker Pulse-generator1 death26 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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