MozecTM NC Rx PTCA Balloon Dilatation CatheterRecalls & reported problems across all models

We found 15 models of MozecTM NC Rx PTCA Balloon Dilatation Catheter by Meril Life Sciences Private Limited in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2017 and Oct 21, 2023 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (6 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

Most reported MozecTM NC Rx PTCA Balloon Dilatation Catheter problems

MozecTM NC Rx PTCA Balloon Dilatation Catheter models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC25015

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  3 reports
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC30015

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  3 reports
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC30013

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  2 reports
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC20008

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC20015

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC25013

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC25028

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC27515

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC30023

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC35008

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC35013

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC35015

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC40008

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC25035

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report
• MozecTM NC Rx PTCA Balloon Dilatation Catheter MNC45013

  Catheters, Transluminal Coronary Angioplasty, Percutaneous
  1 report

Recent MozecTM NC Rx PTCA Balloon Dilatation Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2023Deflation Problem; Deflation Problem

  AS REPORTED, 4.50X13 MM MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS MID RCA WITH SEVERE TORTUOSITY, 80% CALCIFICATION AND 80% STENOSIS. THE BALLOON WAS PLACED MID TO PROXIMAL IN THE RCA. THE BALLOON DID NOT DEFLATE DURING THE PROCEDURE. (THE BALLON TOOK 1.5 - 2 MINUTES TO DEFLATE). THE DEVICE WAS USED IN 62 YEARS OLD MALE PATIENT. THE TARGET LESION WAS MID RCA WITH SEVERE TORTUOSITY, 80% CALCIFICATION AND 80% STENOSIS. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY IN REMOVING THE STYLET. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY. THERE WAS NO ANOMALY NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WAS NO UNUSUAL FORCE USED DURING THE LOADING ON GUIDEWIRE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981741 ↗
• MalfunctionApr 28, 2023Failure to Advance; Failure to Deflate; Failure to Advance; Failure to Deflate

  AS REPORTED, 2.75 X 15 MM, MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER WAS USED FOR THE PROCEDURE. IT HAS BEEN STATED THAT THE FLEXIBILITY AND LESION PASSAGE WERE NOT SUFFICIENT, IT WAS CHALLENGING TO PASS THROUGH THE STENT, BALLOON COMPLIANCE WAS LOW, THE DEFLATION WAS DELAYED DURING THE BALLOON DEFLATION AND THAT THIS WAS NOT SUITABLE FOR USE DUE TO THE INCREASE OF PERIPROCEDURAL MI RISK.

  Patient problems: Insufficient Information

  MAUDE report 16829434 ↗
• MalfunctionDec 13, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  AS REPORTED, 3.00 X 15 MM MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER WAS USED FOR THE PROCEDURE. IT HAS BEEN STATED THE TRANSITION PROFILE WAS INSUFFICIENT IN THE TRANSITION INTO THE VESSEL AND STENT, THE PROCEDURES WERE FAILURE DUE TO LACK OF SUFFICIENT FLEXIBILITY AND LUBRICITY, THE BALLOON COMPLIANCE WAS LIMITED AND THE RISK OF PROCEDURAL MYOCARDIAL INFARCTION INCREASED DUE TO THE DELAY EXPERIENCED DUE TO THE PROBLEM IN RETRACTION OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15967847 ↗
• MalfunctionApr 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED, THE 3.50 X 08 MOZEC NC BALLOON BECAME LODGED ON THE PCI WIRE AND WAS UNABLE TO BE ADVANCED OR REMOVED. THE BALLOON AND WIRE HAD TO BE REMOVED FROM THE PATIENT. ONCE OUT OF THE PATIENT, THE BALLOON WAS STILL LODGED ON THE WIRE AND COULD NOT BE REMOVED. THE PCI WIRE USED WAS A 0.014" BALANCED MIDDLE WEIGHT (BMW) WIRE. A NEW BMW WIRE WAS USED ALONG WITH A 3.5 X 8 NC QUANTUM BALLOON (BOSTON SCI) TO COMPLETE THE CASE. THERE WAS NO ADVERSE EVENT OR HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT. THE SHEATH USED WAS A 6F RAIN SHEATH IN THE RIGHT RADIAL ARTERY. THE GUIDING CATHETER USED WAS A 6F XB3.5 VISTA BRITE TIP GUIDING CATHETER. THE BALLOON CATHETER WAS PREPPED IN THE USUAL FASHION PER THE IFU. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER PRIOR TO LOADING ON THE WIRE. THE BALLOON WAS NEVER INFLATED, AS IT BECAME LODGED ON THE WIRE PRIOR TO EXITING THE GUIDING CATHETER. THE BALLOON CATHETER WAS STORED ON A SUPPLY CART IN THE PROCEDURE AREA WITH CONTROLLED TEMPERATURE AND HUMIDITY. THE DEVICE WAS USED FOR THE 87 YEARS OLD PERSON WEIGHING 68 KG. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY IN REMOVING THE PROTECTIVE BALLOON COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640076 ↗
• MalfunctionMar 16, 2020Retraction Problem; Retraction Problem

  AS REPORTED, 3.00 X 15MM MOZEC(TM) NC RX PTCA BALLOON DILATATION CATHETER, BATCH #: MNCO52 WAS USED IN A PCI. WHILE WITHDRAWING, IT WAS VERY DIFFICULT TO RETRIEVE WITHOUT TAKING THE GUIDE WIRE. THIS INCREASE THE RADIATION TIME.

  Patient problems: No Information

  MAUDE report 9834371 ↗
• MalfunctionMar 9, 2020Material Deformation; Material Deformation

  AS REPORTED, A 3.00 X 13 MM MOZECTM NC - RX PTCA BALLOON DILATATION CATHETER WAS USED FOR A POST DILATION OF A STENT. IT DID NOT POST DILATE THE DEPLOYED ONYX STENT. THE BLUE PART OF THE SHAFT LOOKS WITH DEFECT. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS USED FOR THE MALE TO POST DILATE A STENT. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY IN REMOVING THE PROTECTIVE BALLOON COVER OR THE STYLET. THERE WERE NO ANOMALIES NOTED TO THE DEVICE PRIOR TO USE. THE DEVICE WAS STORED AND HANDLED PER THE IFU. THE DEVICE WAS PREPPED PER THE IFU. THERE WERE NO KINKS OR OTHER DAMAGES NOTED TO THE DEVICE PRIOR TO INSERTING INTO THE PATIENT. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HAEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER. THERE WAS NO UNUSUAL FORCE USED DURING THE LOADING ON THE GUIDE WIRE. THERE WAS NO RESISTANCE OR ABNORMAL DEVICE INTERACTION NOTICED DURING ADVANCEMENT. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO RESISTANCE OR ABNORMAL DEVICE INTERACTION NOTICED DURING LESI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9804182 ↗
• MalfunctionNov 30, 2019Material Rupture; Material Rupture

  AS REPORTED, A 2.50 X 35 MM MOZECTM NC - RX PTCA BALLOON DILATATION CATHETER WAS USED FOR THE PROCEDURE. DURING INFLATION THE BALLOON BURST. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9392241 ↗
• MalfunctionDec 11, 2018Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A 3.0X13 MOZEE NC WAS DIFFICULT TO REMOVE FROM SION BLUE WIRE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS STORED AND HANDLED AS PER THE IFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE AND THE DEVICE WAS REMOVED FROM THE PACKAGE WITHOUT ENCOUNTERING ANY DIFFICULTY. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP AND IN REMOVING THE PROTECTIVE BALLOON COVER. THE PRODUCT WAS NORMALLY PREPPED FOLLOWING THE IFU WITHOUT USING ANY EXCESS FORCE. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. NO ANOMALIES WERE NOTED DURING OR AFTER THE DEVICE WAS PREPPED. NO VISIBLE SIGNS OF KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. NO RESISTANCE I FRICTION WAS EXPERIENCED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND WHILE CROSSING THE TARGET LESION. NO VISIBLE SIGNS OF KINK OR DAMAGE WERE NOTED ANYTIME DURING THE PROCEDURE AND NO UNUSUAL FORCE WAS APPLIED ANYTIME DURING THE PROCEDURE. THERE WAS NO DIFFICULTY ENCOUNTERED WHEN CONNECTING THE HUB TO THE INDEFLATOR AND THE DEVICE WAS NOT ADVANCED WITH THE INDEFLATOR CONNECTED TO THE HUB. THE BALLOON WAS INFLATED NORMALLY A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8150942 ↗
• MalfunctionOct 16, 2018Entrapment of Device; Entrapment of Device

  A 2.50 X 15 MOZEC¿ NC BALLOON WAS DIFFICULT TO REMOVE FROM A SION BLUE GUIDEWIRE AFTER POST DILATING A LESION. THE ARTERY INTERVENED WAS TORTUOUS. FIRST, A 2.50 X 15 MOZEC¿ NC WAS USED ON A WHISPER J WIRE AFTER ROTOBLADING. A 2.50 X 15 MOZEC¿ NC WAS THEN TAKEN UP TO 20 ATM. THE PHYSICIAN THEN SWITCHED TO A SION BLUE GUIDEWIRE, STENTED AND THEN POST DILATED WITH THE SAME MOZEC¿ NC WHICH WAS TAKEN UP TO 24 ATM. UPON REMOVING BALLOON FROM THE GUIDE CATHETER, HE NOTICED THAT IT BECAME DIFFICULT IN THE MID TO THIRD PART PROXIMAL OF THE GUIDEWIRE. A HEMOSTAT WAS THEN USED TO HELP HOLD THE GUIDEWIRE AND REMOVE THE BALLOON CATHETER. THE VESSEL WAS TORTUOUS. THERE WERE NO DIFFICULTIES IN REMOVING THE PRODUCT FROM THE HOOP. THERE WERE NO DIFFICULTIES IN REMOVING THE PROTECTIVE BALLOON COVER OR THE STYLET. THERE WERE NO DIFFICULTIES IN REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO PATIENT. THE DEVICE WAS STORED AND PREPARED AS PER THE IFU. THERE WAS NO DEVICE KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970098 ↗
• MalfunctionSep 17, 2018Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  THE SURGEON USED A 2.0X15 MOZEC NC TO PRE-DILATE A LESION DURING A CORONARY INTERVENTION. THE BALLOON WAS INFLATED AND DEFLATED FOUR ( 4) TIMES. WHEN TRYING TO REMOVE THE BALLOON, IT GOT STUCK ON THE SION BLUE WIRE. THE SION BLUE WIRE WAS REMOVED WITH MOZEC BALLOON STILL ON IT. THE VESSEL WAS RE-WIRED TO COMPLETE THE PROCEDURE WITH A NON-MERIL DEVICE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882779 ↗
• InjuryAug 29, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, AFTER OPENING THE BLOCKAGE AND DEFLATING THE BALLOON, RESISTANCE WAS FELT DURING REMOVAL OF THE MOZECTM BALLOON CATHETER (NC RX PTCA 2.5.00 MM X 30 MM). THE DOCTOR FELT THE BALLOON CATHETER JUMP BACK AND, AFTER REMOVAL, FOUND THAT THE DEVICE CAME APART AT THE RX PORT AND THE DISTAL PART OF THE BALLOON WAS STILL IN THE PATIENT. THE DOCTOR ATTEMPTED REMOVAL USING A NON-CORDIS DEVICE UNSUCCESSFULLY. THE DOCTOR ENDED UP TRAPPING THE SEPARATED PIECE USING AN UNKNOWN BALLOON AND WAS ABLE TO REMOVE THE SEPARATED SECTION. THE PROCEDURE STARTED AS A TOTAL HEART CATHETERIZATION BUT TURNED INTO AN INTERVENTION TO THE DISTAL RIGHT CORONARY ARTERY (RCA). THE RCA WAS DESCRIBED AS HEAVILY CALCIFIED AND TORTUOUS. THE TARGET ARTERY WAS INITIALLY ACCESSED USING A NON-CORDIS GUIDE CATHETER, A NON-CORDIS GUIDEWIRE AND A NON-CORDIS GUIDE EXTENSION. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH SIX ELUNIR STENTS BEING IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS NOT RESTERILIZED. NO ANOMALIES WERE NOTED WHEN REMOVED FROM THE PACKAGE. NO ANOMALIES WERE NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7829221 ↗
• MalfunctionMay 30, 2018Device Operational Issue; Difficult to Advance; Positioning Problem; Device Operational Issue; Difficult to Advance; Positioning Problem

  A 2.0 X 8 MOZEC NC WAS ADVANCED TO A LESION IN THE RV MARGINAL BRANCH BUT IT COULD NOT CROSS THE LESION. ANOTHER PTCA CATHETER (BSC - 2.0 X 8 NC EMERGE) USED AND THE PROCEDURE COMPLETED. NO ISSUE TO THE PATIENT NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553235 ↗
• MalfunctionMay 7, 2018Sticking; Device Issue; Physical Resistance; Physical Property Issue; Sticking; Device Issue; Physical Resistance; Physical Property Issue

  THE MOZEC 2.5 X 15 MM NC WAS USED TO POST DILATE WHILE ON ASAHI 0.014" FIELDER XT-A WIRE. THE BALLOON WAS INFLATED TO 20 RBP AND IT APPEARED TO BE WORKING WELL. AFTER DEFLATING MOZEC BALLOON, FELLOW DR. (B)(6) NOTICED IT WAS SLIGHTLY DIFFICULT TO MOVE BACK. WAS ABLE TO GET BALLOON AND WIRE BACK INTO GUIDE CATHETER. THEN, HAD TO CLAMP THE WIRE TO GET MOZEC NC BALLOON OFF OF THE ASAHI FIELDER XT-A WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7491074 ↗
• MalfunctionApr 26, 2018Sticking; Physical Resistance; Device Operational Issue; Physical Property Issue; Sticking; Physical Resistance; Device Operational Issue; Physical Property Issue

  THE DEVICE WAS TAKEN UP OVER THE RATED BURST PRESSURE (RBP) AND STUCK TO THE WIRE. IT WAS VERY DIFFICULT TO TAKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7464300 ↗
• MalfunctionApr 19, 2018Mechanical Problem; Difficult to Remove; Physical Property Issue; Positioning Problem; Mechanical Problem; Difficult to Remove; Physical Property Issue; Positioning Problem

  THE BALLOON WAS TAKEN ABOVE RATED BURST PRESSURE (RBP) AND WAS DIFFICULT TO REMOVE FROM THE BODY. IT WAS STICKING TO THE WIRE BUT WAS EVENTUALLY REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7443852 ↗