LifeStreamRecalls & reported problems across all models
Clearstream Technologies Limited · 37 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 334
- Deaths reported
- 2
- Injuries reported
- 35
- Recalls
- 0
We found 37 models of LifeStream by Clearstream Technologies Limited in the FDA's device registry (GUDID). Together they are named in 334 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2017 and Aug 5, 2026 — classified as 2 deaths, 35 injuries, 297 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (242 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LifeStream problems
Device problems
- Device Dislodged or Dislocated242
- Device-Device Incompatibility70
- Failure to Advance30
- Material Deformation19
- Retraction Problem14
- Difficult to Open or Remove Packaging Material13
- Migration or Expulsion of Device12
- Material Rupture9
Patient problems
- No Clinical Signs, Symptoms or Conditions202
- No Consequences Or Impact To Patient63
- No Patient Involvement21
- No Known Impact Or Consequence To Patient17
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Foreign Body In Patient6
- Injury4
- Vascular Dissection3
LifeStream models
37 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LifeStream LSMU1350637Iliac covered stent, arterial32 reports
- LifeStream LSMU1350726Iliac covered stent, arterial31 reports
- LifeStream LSMU0800726Iliac covered stent, arterial28 reports
- LifeStream LSMU1350526Iliac covered stent, arterial17 reports
- LifeStream LSMU0800938Iliac covered stent, arterial16 reports
- LifeStream LSMU0800637Iliac covered stent, arterial1 death15 reports
- LifeStream LSMU0800858Iliac covered stent, arterial14 reports
- LifeStream LSMU0800958Iliac covered stent, arterial14 reports
- LifeStream LSMU1350626Iliac covered stent, arterial13 reports
- LifeStream LSMU0800837Iliac covered stent, arterial13 reports
- LifeStream LSMU1350837Iliac covered stent, arterial1 death13 reports
- LifeStream LSMU1350858Iliac covered stent, arterial13 reports
- LifeStream LSMU1350737Iliac covered stent, arterial11 reports
- LifeStream LSMU0800826Iliac covered stent, arterial10 reports
- LifeStream LSMU1350826Iliac covered stent, arterial10 reports
- LifeStream LSMU0800626Iliac covered stent, arterial8 reports
- LifeStream LSMU0800758Iliac covered stent, arterial8 reports
- LifeStream LSMU1350616Iliac covered stent, arterial8 reports
- LifeStream LSMU1350758Iliac covered stent, arterial6 reports
- LifeStream LSMU1350958Iliac covered stent, arterial6 reports
- LifeStream LSMU1350716Iliac covered stent, arterial6 reports
- LifeStream LSMU0800737Iliac covered stent, arterial5 reports
- LifeStream LSMU1350938Iliac covered stent, arterial5 reports
- LifeStream LSMU0800616Iliac covered stent, arterial5 reports
- LifeStream LSMU1350537Iliac covered stent, arterial4 reports
- LifeStream LSMU0801038Iliac covered stent, arterial3 reports
- LifeStream LSMU0800716Iliac covered stent, arterial3 reports
- LifeStream LSMU1350816Iliac covered stent, arterial3 reports
- LifeStream LSMU0800526Iliac covered stent, arterial2 reports
- LifeStream LSMU1350658Iliac covered stent, arterial2 reports
- LifeStream LSMU0801238Iliac covered stent, arterial2 reports
- LifeStream LSMU0801258Iliac covered stent, arterial2 reports
- LifeStream LSMU1351258Iliac covered stent, arterial2 reports
- LifeStream LSMU0800537Iliac covered stent, arterial1 report
- LifeStream LSMU0801058Iliac covered stent, arterial1 report
- LifeStream LSMU1351058Iliac covered stent, arterial1 report
- LifeStream LSMU1351238Iliac covered stent, arterial1 report
Recent LifeStream adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 5, 2026Device Dislodged or Dislocated; Material Deformation
On (b)(6) 2026, a patient underwent a stent placement procedure using a Life stream device. During the procedure, it was reported that the stent detached from the delivery system and required retrieval using a snare. The detachment was noted after the stent delivery system had been positioned at the intended treatment site within the subclavian artery. Angiography was performed to confirm device position prior to deployment, at which time it was observed that the stent was no longer mounted on the delivery shaft. The stent was subsequently located in the brachial artery. The procedure was prolonged and was subsequently completed using another device. The patient's current condition was unknown.
Patient problems: Foreign Body In Patient
MAUDE report 50144024 ↗MalfunctionJul 20, 2026Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25870392 ↗MalfunctionJul 19, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25867868 ↗InjuryJul 9, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM DEVICE FOR LEFT RENAL ARTERY STENOSIS. PRE DEPLOYMENT EVALUATION DEMONSTRATED THAT THE LESION WAS HIGHLY FOCAL, WITH A SIGNIFICANT PORTION OF THE STENT EXPECTED TO EXTEND INTO THE AORTA. AT THAT POINT, A DECISION WAS MADE TO REMOVE THE DEVICE AND USE ANOTHER STENT. THE STENT WAS WITHDRAWN, AND INSPECTION REVEALED THAT IT HAD DISLODGED FROM THE BALLOON WITHIN THE LEFT RENAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO SNARE THE STENT; HOWEVER, THESE WERE UNSUCCESSFUL. THE STENT ULTIMATELY BECAME LODGED IN A SEGMENTAL BRANCH OF THE RENAL ARTERY, WHICH HAD SPASMED AROUND IT, RENDERING IT UNRETRIEVABLE. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 25769149 ↗MalfunctionJul 8, 2026Device Dislodged or Dislocated
On (b)(6) 2026, a patient was prepped for a stent placement procedure using a Lifestream device. The reporter stated that they were not present during the case; information was provided by the technician. The vessel was predilated and adequately prepared prior to stent insertion. However, the stent was allegedly dislodged before deployment and was not used in the patient. There was no reported patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25747479 ↗MalfunctionJun 23, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM DEVICE. DURING INSERTION, WHILE ADVANCING THE DEVICE INTO A SEVENTH FRENCH COOK ANSEL SHEATH, THE STENT BECAME DISLODGED FROM THE BALLOON WHILE BEING ADVANCED INTO THE SHEATH. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25592971 ↗MalfunctionJun 18, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, A PATIENT UNDERWENT A BALLOON EXPANDABLE STENT GRAFT USING THE LIFESTREAM DEVICE. DURING THE PROCEDURE, THE INITIALLY INTENDED STENT WAS DISLODGED DURING PLACEMENT DUE TO INTERFERENCE AND WAS FAILED TO COVER THE LESION, NECESSITATING PLACEMENT OF AN ADDITIONAL STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547036 ↗MalfunctionJun 16, 2026Device-Device Incompatibility
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM DEVICE. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL WAS UNABLE TO PROPERLY INSERT THE DEVICE INTO THE SHEATH. CONSEQUENTLY, THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25514484 ↗MalfunctionJun 10, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM DEVICE. DURING THE PROCEDURE, THE STENT DISLODGED FROM THE BALLOON BEFORE REACHING THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25454164 ↗InjuryJun 9, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTREAM. IT WAS REPORTED THAT DELIVERY WAS ATTEMPTED VIA THE CONTRALATERAL APPROACH. HOWEVER, THE STENT DISLODGED JUST PROXIMAL TO THE CONTRALATERAL LESION. THE STENT REMAINED IMPLANTED WITHIN THE BODY, THE DELIVERY SYSTEM WAS WITHDRAWN THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 25442438 ↗MalfunctionMay 20, 2026Migration or Expulsion of Device; Device Dislodged or Dislocated
A PATIENT UNDERWENT A BALLOON EXPANDABLE STENT GRAFT PROCEDURE USING THE LIFESTREAM DEVICE. DURING THE PROCEDURE, THE SHEATH AND STENT BEGAN TO MIGRATE OFF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225962 ↗MalfunctionMay 8, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT CAME NOT MOUNTED ON THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124244 ↗MalfunctionApr 28, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTREAM. WHILE DOING THE PROCEDURE, BALLOONS MOUNTED STENT CAME DISLODGED WHEN TRYING TO GO INTO SHEATH AND IT WAS SUCCESSFULLY RECOVERED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25011598 ↗MalfunctionApr 24, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTREAM. THE STENT FELL OFF THE SHAFT DURING DEPLOYMENT IN THE SHEATH TARGETING THE SMA VESSEL. THE LIFESTREAM WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24979528 ↗MalfunctionApr 18, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTREAM. IT WAS REPORTED THAT DURING PROCEDURE, THE STENT DISLODGED FROM THE BALLOON ON WHICH IT WAS MOUNTED BEFORE REACHING THE LESION. THE DISLODGED STENT HAS BEEN RETRIEVED FROM THE BODY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919228 ↗
Other Clearstream Technologies Limited products
All Clearstream Technologies Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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