SYNERGY XDRecalls & reported problems across all models
Boston Scientific Corporation · 65 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,106
- Deaths reported
- 52
- Injuries reported
- 249
- Recalls
- 0
We found 65 models of SYNERGY XD by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,106 adverse event reports in the FDA's MAUDE database, received between Sep 3, 2020 and Sep 30, 2026 — classified as 52 deaths, 249 injuries, 805 malfunctions.
The most frequently reported specific device problem is “Break” (354 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 SYNERGY XD problems
Device problems
- Break354
- Device Dislodged or Dislocated244
- Failure to Advance241
- Material Deformation239
- Difficult to Remove130
- Adverse Event Without Identified Device or Use Problem99
- Difficult to Advance96
- Material Rupture45
Patient problems
- No Clinical Signs, Symptoms or Conditions892
- Foreign Body In Patient60
- Thrombosis/Thrombus33
- Vascular Dissection31
- Chest Pain30
- No Consequences Or Impact To Patient27
- Non specific EKG/ECG Changes25
- Cardiac Arrest24
SYNERGY XD models
65 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SYNERGY™ XD H7493941848400Coronary drug-eluting stent56 reports
- SYNERGY™ XD H7493941848300Coronary drug-eluting stent2 deaths54 reports
- SYNERGY™ XD H7493941816300Coronary drug-eluting stent1 death48 reports
- SYNERGY™ XD H7493941838300Coronary drug-eluting stent3 deaths43 reports
- SYNERGY™ XD H7493941848350Coronary drug-eluting stent2 deaths37 reports
- SYNERGY™ XD H7493941820400Coronary drug-eluting stent1 death35 reports
- SYNERGY™ XD H7493941816250Coronary drug-eluting stent1 death34 reports
- SYNERGY™ XD H7493941828300Coronary drug-eluting stent3 deaths32 reports
- SYNERGY™ XD H7493941832300Coronary drug-eluting stent1 death31 reports
- SYNERGY™ XD H7493941838400Coronary drug-eluting stent31 reports
- SYNERGY™ XD H7493941848250Coronary drug-eluting stent29 reports
- SYNERGY™ XD H7493941828250Coronary drug-eluting stent1 death28 reports
- SYNERGY™ XD H7493941816350Coronary drug-eluting stent1 death28 reports
- SYNERGY™ XD H7493941820350Coronary drug-eluting stent1 death28 reports
- SYNERGY™ XD H7493941820300Coronary drug-eluting stent3 deaths26 reports
- SYNERGY™ XD H7493941824300Coronary drug-eluting stent4 deaths25 reports
- SYNERGY™ XD H7493941838350Coronary drug-eluting stent3 deaths25 reports
- SYNERGY™ XD H7493941812300Coronary drug-eluting stent1 death24 reports
- SYNERGY™ XD H7493941816220Coronary drug-eluting stent22 reports
- SYNERGY™ XD H7493941812220Coronary drug-eluting stent1 death21 reports
- SYNERGY™ XD H7493941816400Coronary drug-eluting stent1 death21 reports
- SYNERGY™ XD H7493941820250Coronary drug-eluting stent20 reports
- SYNERGY™ XD H7493941832400Coronary drug-eluting stent2 deaths19 reports
- SYNERGY™ XD H7493941824250Coronary drug-eluting stent1 death18 reports
- SYNERGY™ XD H7493941838250Coronary drug-eluting stent1 death18 reports
- SYNERGY™ XD H7493941838220Coronary drug-eluting stent1 death17 reports
- SYNERGY™ XD H7493941812250Coronary drug-eluting stent1 death17 reports
- SYNERGY™ XD H7493941812350Coronary drug-eluting stent1 death17 reports
- SYNERGY™ XD H7493941824350Coronary drug-eluting stent1 death16 reports
- SYNERGY™ XD H7493941832350Coronary drug-eluting stent1 death16 reports
- SYNERGY™ XD H7493941812400Coronary drug-eluting stent16 reports
- SYNERGY™ XD H7493941832250Coronary drug-eluting stent2 deaths15 reports
- SYNERGY™ XD H7493941828350Coronary drug-eluting stent2 deaths15 reports
- SYNERGY™ XD H7493941824400Coronary drug-eluting stent15 reports
- SYNERGY™ XD H7493941820220Coronary drug-eluting stent14 reports
- SYNERGY™ XD H7493941812270Coronary drug-eluting stent2 deaths13 reports
- SYNERGY™ XD H7493941828220Coronary drug-eluting stent11 reports
- SYNERGY™ XD H7493941816270Coronary drug-eluting stent10 reports
- SYNERGY™ XD H7493941828400Coronary drug-eluting stent10 reports
- SYNERGY™ XD H7493941816500Coronary drug-eluting stent10 reports
- SYNERGY™ XD H7493941848270Coronary drug-eluting stent10 reports
- SYNERGY™ XD H7493941838270Coronary drug-eluting stent9 reports
- SYNERGY™ XD H7493941824270Coronary drug-eluting stent2 deaths8 reports
- SYNERGY™ XD H7493941820450Coronary drug-eluting stent8 reports
- SYNERGY™ XD H7493941824450Coronary drug-eluting stent8 reports
- SYNERGY™ XD H7493941808220Coronary drug-eluting stent7 reports
- SYNERGY™ XD H7493941824220Coronary drug-eluting stent1 death7 reports
- SYNERGY™ XD H7493941832270Coronary drug-eluting stent7 reports
- SYNERGY™ XD H7493941808300Coronary drug-eluting stent7 reports
- SYNERGY™ XD H7493941832500Coronary drug-eluting stent7 reports
- SYNERGY™ XD H7493941808350Coronary drug-eluting stent1 death6 reports
- SYNERGY™ XD H7493941832450Coronary drug-eluting stent6 reports
- SYNERGY™ XD H7493941812500Coronary drug-eluting stent6 reports
- SYNERGY™ XD H7493941820500Coronary drug-eluting stent6 reports
- SYNERGY™ XD H7493941820270Coronary drug-eluting stent2 deaths5 reports
- SYNERGY™ XD H7493941832220Coronary drug-eluting stent4 reports
- SYNERGY™ XD H7493941808270Coronary drug-eluting stent1 death4 reports
- SYNERGY™ XD H7493941828270Coronary drug-eluting stent4 reports
- SYNERGY™ XD H7493941808400Coronary drug-eluting stent4 reports
- SYNERGY™ XD H7493941828500Coronary drug-eluting stent4 reports
- SYNERGY™ XD H7493941812450Coronary drug-eluting stent3 reports
- SYNERGY™ XD H7493941816450Coronary drug-eluting stent3 reports
- SYNERGY™ XD H7493941828450Coronary drug-eluting stent3 reports
- SYNERGY™ XD H7493941824500Coronary drug-eluting stent3 reports
- SYNERGY™ XD H7493941808250Coronary drug-eluting stent2 reports
Recent SYNERGY XD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Rupture
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified coronary artery. A 5.00 x 16mm Synergy XD drug-eluting stent (DES) was advanced for treatment. However, during initial inflation at 10 atmospheres, the balloon ruptured. The device was removed, and the procedure was completed with another of same device. There were no patient complications reported, and the patient was stable following the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947819 ↗MalfunctionSep 30, 2026Difficult to Advance; Device Dislodged or Dislocated
Patient problems: Foreign Body In Patient
MAUDE report 50946743 ↗MalfunctionSep 28, 2026Device Dislodged or Dislocated; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922594 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902890 ↗InjurySep 25, 2026Fracture; Difficult to Remove; Material Rupture; Activation Failure; Failure to Deflate
It was reported that multiple device issue occurred requiring additional intervention.The target lesion was located in a non-tortuous vessel. The 2.50 x 38 mm Synergy XD drug eluting stent was selected for use. The technician noted resistance upon removing the balloon protector and stylet from the stent delivery system (SDS) and informed the physician. The physician did not notice any visible damage to the SDS balloon and decided to use the device. Upon advancing the stent to the lesion, the physician got the stent in the correct position and told the scrub technician to inflate/deploy the stent. During the attempt to deploy the stent at 12 atm, the inflation device kept spinning as if it was being inflated, but the balloon never completely inflated, and the stent seemed to only partially deploy around 2 atm. Upon trying to remove the device, the balloon appeared to not have deflated properly and became stuck. Another physician was consulted and the decision was made to remove everything as a whole, the guide catheter, guidewire, and SDS. When the system was pulled, the balloon snagged and caused the stent to fracture into two pieces. The SDS was removed as a whole, but the fractur
Patient problems: Foreign Body In Patient
MAUDE report 50893170 ↗InjurySep 25, 2026Difficult to Remove; Failure to Deflate
It was reported that deflation failure occurred resulting in patient complications and additional intervention.The left anterior descending (LAD) coronary artery was noted to provide two diagonal branches and terminated as the apical recurrent branch. The proximal LAD was noted to have diffuse long 50 to 60% disease with 80 to 90% mid disease. Following atherectomy of the LAD, direct stenting was performed with a 2.75 x 38 mm Synergy XD drug eluting stent. The stent delivery system (SDS) balloon was inflated for 10-15 seconds during stent implantation and post implant, was deflated for 20 seconds before attempting to pull back the device. The proximal segment remained inflated, however, and only the distal portion of the balloon was deflated. The SDS was stuck in the patient for approximately 20 minutes and during that time, the patient reported chest pain and ST elevations were noted. Multiple attempts were made to puncture the inflated balloon with different wires and micro catheters, but all failed. A 3-way stop cock was then connected and the technician continued to draw negative until the balloon deflated and was removed. The open-heart team had been called to perform further
Patient problems: Chest Pain; Non specific EKG/ECG Changes
MAUDE report 50893097 ↗MalfunctionSep 24, 2026Device-Device Incompatibility; Device Dislodged or Dislocated
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention. The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery. During the procedure, a 7F guide catheter and a Guidezilla II guide extension catheter were used. After the lesion was pre-dilated with a 2.00mm Emerge balloon catheter, a 2.25 x 20mm SYNERGY? XD was advanced for treatment. During insertion, the stent got caught on the Guidezilla and started to dislodge from the delivery system. The physician removed the delivery system, and guide extension together, retrieving the dislodged stent with no stent left behind. The Guidezilla was reinserted, and a new stent was then introduced and successfully deployed. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877502 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a grade C dissection occurred. The 3.0 mm x 36 mm target lesion located at the mid right coronary artery (mid RCA) was pretreated with a 3.0 x 15 mm non-compliant balloon angioplasty catheter resulting in 40% stenosis and TIMI flow 3. The target lesion was then treated with the 3.0 mm x 38 mm Synergy XD stent. During the stent placement a stent edge dissection caused by the stent placement occurred. The dissection was a type C that extended into the distal RCA and required placement of two stents to resolve the issue. The event was resolved and the patient discharged.
Patient problems: Vascular Dissection
MAUDE report 50860042 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction
MAUDE report 50551622 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported elevated cardiac enzymes and Myocardial Infarction occurred. The patient was on a prior regimen of Aspirin (>= 72 hours) and antiplatelet medication other than Aspirin (>= 72 hours). At the time of the procedure, the patient received Heparin or other antithrombotic medication. The 2.75 mm x 28 mm target lesion located in the main branch of the proximal left anterior descending vessel (LAD) was pretreated with three devices using the largest balloon diameter of 2.5 mm x 12 mm Wolverine cutting balloon, semi-compliant balloon angioplasty catheter and non-compliant balloon angioplasty catheter resulting in 30% residual stenosis and TIMI flow of 3. The lesion was then successfully treated with the 2.75 mm x 32 mm Synergy XD drug eluting stent achieving 0% residual stenosis with TIMI flow of 3. A balloon angioplasty catheter (PTCA dilatation catheter) and a non-complaint balloon was used for post dilation as ancillary devices. The 2.5 mm x 20 mm target lesion located in the side branch of the 1st diagonal vessel was pretreated with three devices using the largest balloon diameter of 2.5 mm x 15 mm Wolverine cutting balloon, semi-compliant balloon angioplasty catheter and
Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction
MAUDE report 50550385 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported elevated cardiac enzymes and Myocardial Infarction occurred. The patient was on a prior regimen of Aspirin (>= 72 hours) and antiplatelet medication other than Aspirin (>= 72 hours). At the time of the procedure, the patient received Heparin or other antithrombotic medication. The 2.75 mm x 28 mm target lesion located in the main branch of the proximal left anterior descending vessel (LAD) was pretreated with three devices using the largest balloon diameter of 2.5 mm x 12 mm Wolverine cutting balloon, semi-compliant balloon angioplasty catheter and non-compliant balloon angioplasty catheter resulting in 30% residual stenosis and TIMI flow of 3. The lesion was then successfully treated with the 2.75 mm x 32 mm Synergy XD drug eluting stent achieving 0% residual stenosis with TIMI flow of 3. A balloon angioplasty catheter (PTCA dilatation catheter) and a non-complaint balloon was used for post dilation as ancillary devices. The 2.5 mm x 20 mm target lesion located in the side branch of the 1st diagonal vessel was pretreated with three devices using the largest balloon diameter of 2.5 mm x 15 mm Wolverine cutting balloon, semi-compliant balloon angioplasty catheter and
Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction
MAUDE report 50550334 ↗InjuryAug 12, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229880 ↗MalfunctionAug 6, 2026Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165322 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient complications occurred. The patient was on GPIIb/IIIa inhibitors and on prior regimen of Aspirin (>= 72 hours) and antiplatelet other than Aspirin (>= 72 hours) at the time of the procedure. A loading dose of 300mg of clopidogrel was given prior to the procedure. The 40 mm x 2.00 mm target lesion was located in the first obtuse marginal branch of the left circumflex artery (LCx) and was pre-treated with a 2.00 mm x 30 mm semi-compliant balloon angioplasty catheter resulting in 0% residual stenosis and TIMI flow 3. The target lesion was then successfully treated with a 2.25 mm x 38 mm Synergy XD drug eluting stent resulting in 0% residual stenosis and TIMI flow of 3. A non-target lesion extending from the distal left anterior descending artery (LAD) to the mid LAD was successfully treated prior to the treatment of target lesion using a 2.25 mm x 38 mm drug eluting stent and a 2.50 mm x 16 mm drug eluting stent. Post-procedure, elevated cardiac enzymes were detected and the patient was diagnosed with myocardial infarction. The patient was discharged from the hospital with the continuation of aspirin and clopidogrel medications.
Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction
MAUDE report 50073594 ↗MalfunctionJun 18, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. DURING REMOVAL OF A 3.00 X 20MM SYNERGY? XD DRUG-ELUTING STENT FROM THE HOOP, THE STENT WAS FOUND NOT TO BE PROPERLY MOUNTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553602 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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