Guider Softip XFRecalls & reported problems across all models
Boston Scientific Corporation · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
16 open recalls name at least one Guider Softip XF model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 16
We found 17 models of Guider Softip XF by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between May 17, 2016 and Dec 15, 2023 — classified as 4 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 reports).
16 FDA recall records name at least one of these models by its device identifier, 16 still open.
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
Guider Softip XF recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0024-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0023-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0022-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0021-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0020-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0019-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0018-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0017-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0016-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0015-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0014-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0013-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0012-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0011-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Z-0009-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Aug 9, 2022Open, Classified
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
Z-1582-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported Guider Softip XF problems
Device problems
- Leak/Splash4
- Break3
- Fracture3
- Peeled/Delaminated2
- Air Leak1
- Material Separation1
- Migration1
Patient problems
- No Consequences Or Impact To Patient8
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
- Muscle Weakness/Atrophy1
- No Known Impact Or Consequence To Patient1
- Paralysis1
- Stroke/CVA1
Guider Softip XF models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Guider Softip™ XF H965100440CATHETER, PERCUTANEOUS2 recalls2 reports
- Guider Softip™ XF H965100480CATHETER, PERCUTANEOUS1 recall3 reports
- Guider Softip™ XF M003101420CATHETER, PERCUTANEOUS1 recall2 reports
- Guider Softip™ XF M003101620CATHETER, PERCUTANEOUS1 recall2 reports
- Guider Softip™ XF M003101440CATHETER, PERCUTANEOUS1 recall1 report
- Guider Softip™ XF M003101480CATHETER, PERCUTANEOUS1 recall1 report
- Guider Softip™ XF H965100420CATHETER, PERCUTANEOUS1 recall0 reports
- Guider Softip™ XF H965100460CATHETER, PERCUTANEOUS1 recall0 reports
- Guider Softip™ XF H965100470CATHETER, PERCUTANEOUS1 recall0 reports
- Guider Softip™ XF M003101430CATHETER, PERCUTANEOUS1 recall0 reports
- Guider Softip™ XF M003101460CATHETER, PERCUTANEOUS1 recall0 reports
- Guider Softip™ XF M003101470CATHETER, PERCUTANEOUS1 recall0 reports
- Guider Softip™ XF M003100620CATHETER, PERCUTANEOUS1 recall0 reports
- Guider Softip™ XF M003100630CATHETER, PERCUTANEOUS1 recall0 reports
- Guider Softip™ XF M003101630CATHETER, PERCUTANEOUS1 recall0 reports
- Guider Softip™ XF M003101500CATHETER, PERCUTANEOUS2 reports
- Guider Softip™ XF H965100520CATHETER, PERCUTANEOUS1 report
Recent Guider Softip XF adverse event reports
The 14 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 15, 2023Fracture; Fracture
IT WAS REPORTED THAT PATIENT WITH STROKE WAS TREATED SUCCESSFULLY. HOWEVER, THE NEXT DAY PATIENT HAD SECOND STROKE AND HAD TO BE RETREATED. PHYSICIAN PERFORMED THROMBECTOMY PROCEDURE TO REMOVE THE CLOT. DURING THE PROCEDURE THE OPERATOR FOUND THE RADIOPAQUE MARKER OF THE SUBJECT GUIDE CATHETER IN THE M1 SEGMENT FROM THE FIRST PROCEDURE. ATTEMPTS WERE MADE TO REMOVE THE MARKER BUT WERE UNSUCCESSFUL AND WAS LEFT INSIDE THE PATIENT¿S ANATOMY. THERE WAS SURGICAL DELAY REPORTED DURING THE PROCEDURE.
Patient problems: Foreign Body In Patient; Muscle Weakness/Atrophy; Paralysis; Stroke/CVA; Syncope/Fainting; Thrombosis/Thrombus
MAUDE report 18334427 ↗MalfunctionMay 23, 2022Peeled/Delaminated; Peeled/Delaminated
THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE CATHETER (SUBJECT DEVICE) PTFE COATING WAS PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14468940 ↗InjuryDec 4, 2020Fracture; Migration; Fracture; Migration
IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE SUBJECT GUIDE CATHETER BROKE AND MOVED TO A DEEP CERVICAL VEIN AND GOT STUCK. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE BROKEN TIP FRAGMENT AND PROCEEDED TO USE THE SUBJECT CATHETER WITHOUT TIP TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO CLINICAL CONSEQUENCES AND THE PATIENT WAS DISCHARGED. IMAGING WAS DONE APPROXIMATELY ONE MONTH POST PROCEDURE AND THE SUBJECT CATHETER TIP FRAGMENT HAD NOT MOVED FROM THE DEEP CERVICAL VEIN LOCATION. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 10946040 ↗MalfunctionNov 8, 2020Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING OF THE CATHETER (SUBJECT DEVICE) WAS PEELING SPONTANEOUSLY SHOWING THE INNER METAL LAYER WHEN THE SUBJECT CATHETER WAS REMOVED FROM ITS PACKAGING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10806436 ↗InjuryDec 10, 2019Fracture; Fracture
IT WAS REPORTED THAT DURING PROCEDURE, THE GUIDE CATHETER (SUBJECT DEVICE) DISTAL RADIOPAQUE MARKER CAME OFF DURING EMBOLIZATION OF A DURAL FISTULA. THE OPERATOR CHANGED THE INITIAL SHEATH TO A 12F SHEATH AND EXCHANGED THE GUIDEWIRE. THEN THE OPERATOR INFLATED A 8 X 4 BALLOON INSIDE THE TIP RING THAT BROKE OFF AND MANAGED TO RETRIEVE THE TIP FROM THE PATIENT. THIS WAS POSSIBLE AS THE WIRE KEPT THE RADIOPAQUE TIP CONSTRAINED INSIDE THE PATIENT. THERE WAS 1 HOUR SURGICAL DELAY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9448359 ↗MalfunctionApr 8, 2019Break; Break
IT WAS REPORTED THAT A CRACK WAS FOUND IN THE GUIDE CATHETER . THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8493944 ↗InjuryDec 27, 2018Material Separation; Material Separation
IT WAS REPORTED THAT DURING THE STENTING PROCEDURE AT LEFT VERTEBRAL ARTERY FOR COMPLEX CALCIFIED 70% STENOSIS, THE TIP OF THE SUBJECT CATHETER WAS DETACHED AND STUCK IN THE PROXIMAL PART OF THE STENT. WHEN THE PHYSICIAN ADVANCED ANOTHER CATHETER TO THE SUBCLAVIAN ARTERY AND ADVANCED A WIRE THROUGH THE STENT, IT WAS NOTICED THAT THE DETACHED TIP WAS MOVING CLOSER TO THE PROXIMAL END TO THE SUBCLAVIAN PART OF THE STENT. THEREFORE, THE PHYSICIAN DEPLOYED ANOTHER STENT IN THE VERTEBRA ARTERY TO LOCK THE DETACHED TIP BETWEEN THE TWO STENTS. AFTER THE PROCEDURE, THE PATIENT WAS WITH 30% RESIDUAL STENOSIS BUT FREE FLOW AND NO SIGNS OF THE DISTAL EMBOLI. THE PATIENT WAS ADMINISTRATED WITH ACETYLSALICYLIC ACID (ASA) FOR LIFETIME, AND CLOPIDOGREL FOR AT LEAST THREE MONTHS. NO FURTHER INFORMATION IS AVAILABLE FOR NOW.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8200093 ↗MalfunctionOct 6, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE PROCEDURE, A LEAK WAS FOUND BETWEEN THE HUB AND THE CATHETER. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6919461 ↗MalfunctionSep 25, 2017Break; Break
ANALYSIS OF THE DEVICE REVEALED THAT THE GUIDE CATHETER SHAFT WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6890443 ↗MalfunctionJul 11, 2017Break; Break
IT WAS REPORTED THAT THE GUIDE CATHETER (SUBJECT DEVICE) WAS CRACKED /BROKEN. THERE WERE NO PATIENT CLINICAL CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6704409 ↗MalfunctionMay 10, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE PROCEDURE THE GUIDE CATHETER LEAKED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6559292 ↗MalfunctionApr 28, 2017Air Leak; Air Leak
DURING TREATMENT OF A P-COM ANUERYSM, THE PHYSICIAN REPORTED THAT THE GUIDE CATHETER HUB WAS LEAKING. THE PHYSICIAN BELIEVES THAT AIR BUBBLES WERE INSERTED INTO THE GUIDE CATHETER DUE TO THE HUB LEAK AND IT MIGHT CAUSE AIR EMBOLISM TO THE PATIENT. NO PATIENT ADVERSE CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION RECIEVED, INDICATED, THAT AS OF TODAY, THE PATIENT HAS NO NEUROLOGICAL DEFICITS AND IS IN GOOD CONDITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6530922 ↗MalfunctionNov 30, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDE CATHETER LEAKED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6136808 ↗MalfunctionMay 17, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE PROCEDURE, THE PROXIMAL PART OF THE GUIDE CATHETER (SUBJECT DEVICE) LEAKED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5660666 ↗
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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.
How reports and recalls are matched · Editorial policy · Report an error on this page