CoolSculpting Elite Control Unit CS-S3-002-D-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 207 adverse event reports that list this exact device (DI 00816417021619), received between Jul 16, 2021 and Sep 30, 2026 — classified as 206 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Jul 5, 2021Class IITerminated

   An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.

   Z-2383-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 207 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient experienced paradoxical hyperplasia after CoolSculpting treatment on (b)(6) 2026 to the flanks using a Curve 150 Applicator. 2 months post-treatment.

  Patient problems: Hyperplasia

  MAUDE report 50951946 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50937469 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that patient experienced paradoxical hyperplasia to the arm (upper and lower) after treatment on (b)(6) 2021, CoolSculpting Elite System treatment on (b)(6) 2026 using Flat 165 Applicator, and CoolSculpting System on (b)(6) 2021 using the CoolFit Applicator.

  Patient problems: Hyperplasia

  MAUDE report 50936030 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50924006 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that patient experienced "hypertrophy, patient has lost weight since treatment, but the treatment area looks visually thicker and slight bruising on the side" to the inner thighs after CoolSculpting Elite System treatment of (b)(6)2026 using an Curve 150 Applicator and a Flat 165 Applicator.

  Patient problems: Hyperplasia

  MAUDE report 50896469 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported that a patient experienced paradoxical adipose hyperplasia in the abdomen following multiple CoolSculpting treatments administered from (b)(6) 2026. The applicator used was initially unknown, and the event occurred approximately 4.5 months after treatment. The healthcare professional later reported that treatments were performed as follows: (b)(6) 2026: Abdomen treated using a Curve 150 applicator. On (b)(6) 2026: Abdomen and flanks treated using a Curve 120 applicator. And on (b)(6) 2026: Abdomen and flanks treated using a Curve 150 applicator. Healthcare professional described: "photos show a more obtuse abdomen, which is higher in shape/contour and focally pointed compared to baseline" and "Palpation reveals a remarkable "step off" or in this case "Step up" to this central obtuse portion of abdomen. The tissue transitions from a very soft region, to a very firm/rubbery quality".

  Patient problems: Hyperplasia

  MAUDE report 50803152 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient received CoolSculpting treatment over the abdomen with Curve 240 Applicators for the CoolSculpting Elite System, and presented paradoxical hyperplasia 6-8 weeks after treatment. Following treatment was performed on (b)(6) 2026. Later healthcare professional reported "shape around belly button in mid abdomen area, sticking out more than other areas in abdomen" and "can't confirm paradoxical hyperplasia of treated area".

  Patient problems: Hyperplasia

  MAUDE report 50499686 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional that a patient received an unknown CoolSculpting System treatment on the abdomen and flanks with an unknown applicator and experience Paradoxical Hyperplasia post treatment, following treatments performed on (b)(6) 2025 and (b)(6) 2025.

  Patient problems: Hyperplasia

  MAUDE report 50193119 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported ¿pain¿ on the submental area with a Curve 80 applicator for a CoolSculpting Elite System, post-treatment, following treatment performed on (b)(6) 2026, and the patient mentioned that at the clinic where the patient works, they think this could be Paradoxical Hyperplasia. The healthcare professional cannot diagnose the Paradoxical Hyperplasia at this time and mentioned that it was not firm to touch.

  Patient problems: Hyperplasia

  MAUDE report 50178038 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare Professional reported that the patient experiment "firm, shape of applicator on both sides of abdomen", after received treatment with CoolSculpting Elite System using the Flat 165 applicator to abdomen area and subsequently presented with possible Paradoxical Hyperplasia (PH) 6 months post treatment, following treatment performed on (b)(6) 2025.

  Patient problems: Hyperplasia

  MAUDE report 50161157 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported Paradoxical Hyperplasia (PH) on the abdomen and flank areas with a Curve 120 applicator and a Curve 150 applicator for a CoolSculpting Elite System, 3 months post treatment, following treatments performed on (b)(6)2026 and (b)(6)2026. The Flat 125 applicator was used on the inner thighs areas.

  Patient problems: Hyperplasia

  MAUDE report 50114574 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient received CoolSculpting treatment over the submental area and abdomen, with Curve 80, Curve 150 and Curve 240 applicators, and presented Paradoxical Hyperplasia and "nodules, tender, hardened fat" one day after treatment. Following treatments performed on (b)(6)2026.

  Patient problems: Hyperplasia

  MAUDE report 50057129 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient received CoolSculpting treatment over the arms, inner thighs, back, abdomen, flanks, bra fat, "chicken nugget", lateral breast, posterior waist, banana rolls and hips, with Curve 80, Curve 120, Curve 150, Flat 125 and Flat 165 applicators for the CoolSculpting Elite System, and presented Paradoxical Hyperplasia over the back, bra fat, waist, thighs, abdomen, bilateral breast and flanks, seven moths after first treatment. Following treatments performed on (b)(6) 2025, (b)(6) 2025, (b)(6) 2025, (b)(6) 2025, (b)(6) 2025, (b)(6) 2025, (b)(6) 2025, (b)(6) 2025, (b)(6) 2025, (b)(6) 2025 and (b)(6) 2026.

  Patient problems: Hyperplasia

  MAUDE report 50024282 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED COOLSCULPTING TREATMENT OVER THE ABDOMEN, WITH CURVE 240 AND CURVE 150 APPLICATORS, AND PRESENTED PARADOXICAL HYPERPLASIA 4 MONTHS AFTER TREATMENT. FOLLOWING TREATMENTS PERFORMED ON (B)(6) 2025, (B)(6) 2026, AND (B)(6) 2025.

  Patient problems: Hyperplasia

  MAUDE report 25673810 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS TREATED OVER THE ABDOMEN, WITH THE CURVE 150 APPLICATOR, AND PRESENTED WITH PARADOXICAL HYPERPLASIA 2 TO 3 MONTHS AFTER TREATMENT. FOLLOWING TREATMENTS PERFORMED ON (B)(6) 2025.

  Patient problems: Hyperplasia

  MAUDE report 25587961 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED COOLSCULPTING ELITE TREATMENT TO THE ABDOMEN AND FLANKS ON (B)(6) 2024 WITH CURVE 150 AND CURVE 240 APPLICATORS AND WAS PRESENTED WITH PARADOXICAL HYPERPLASIA (PH) POST TREATMENT TO THE FLANKS.

  Patient problems: Hyperplasia

  MAUDE report 25563392 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED PARADOXICAL HYPERPLASIA ON THE ABDOMINAL AREA WITH A CURVE 150 AND A CURVE 240 APPLICATOR FOR A COOLSCULPTING ELITE SYSTEM, 3 MONTHS POST TREATMENT, FOLLOWING TREATMENTS PERFORMED ON (B)(6) 2024, (B)(6) 2024, AND (B)(6) 2024.

  Patient problems: Hyperplasia

  MAUDE report 25445408 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT EXPERIENCED PARADOXICAL HYPERPLASIA (PH) TO ABDOMEN AREA 4 MONTHS AFTER COOLSCULPTING ELITE TREATMENT USING THE CURVE 150 APPLICATOR, FOLLOWING TREATMENTS PERFORMED ON (B)(6) 2025 AND (B)(6) 2026.

  Patient problems: Hyperplasia

  MAUDE report 25429068 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED COOLSCULPTING ELITE TREATMENT TO THE ABDOMEN AND FLANKS ON (B)(6) 2025 AND (B)(6) 2026 WITH CURVE 120 AND CURVE 150 APPLICATORS AND WAS PRESENTED WITH PARADOXICAL HYPERPLASIA (PH) APPROXIMATELY 4 MONTHS POST TREATMENT.

  Patient problems: Hyperplasia

  MAUDE report 25414491 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED PARADOXICAL HYPERPLASIA ON THE ABDOMEN, FLANKS, AND SUBMENTAL AREAS WITH A CURVE 80, CURVE 150 AND CURVE 240 APPLICATORS FOR A COOLSCULPTING ELITE SYSTEM, 3 MONTHS POST-TREATMENT, FOLLOWING TREATMENTS PERFORMED ON (B)(6) 2025, (B)(6) 2026.

  Patient problems: Hyperplasia

  MAUDE report 25393450 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED COOLSCULPTING TREATMENT TO THE ABDOMEN AND LEFT BACK ON (B)(6) 2025 USING THE CURVE 120 AND CURVE 150 APPLICATORS. LATER, THE PATIENT REPORTED LEFT SIDE BACK MASS REMOVED BY SURGICAL INTERVENTION NOT LIPOSUCTION.

  Patient problems: Hyperplasia

  MAUDE report 25385534 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  A PRACTICE DEVELOPMENT MANAGER REPORTED, ON BEHALF OF THE HEALTHCARE PROFESSIONAL, THAT A PATIENT RECEIVED COOLSCULPTING ELITE TREATMENT ON (B)(6) 2025 TO THE LOWER ABDOMEN WITH CURVE 150 APPLICATOR AND THE UPPER ABDOMEN WITH 120 CURVE APPLICATOR AND WAS PRESENTED WITH PARADOXICAL HYPERPLASIA (PH) TO THE LOWER ABDOMEN 2 MONTHS POST TREATMENT.

  Patient problems: Hyperplasia

  MAUDE report 24901546 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A COOLSCULPTING ELITE TREATMENT ON (B)(6) 2025 TO THE ABDOMEN USING THE CURVE 150 APPLICATOR AND PRESENTED WITH PARADOXICAL HYPERPLASIA DESCRIBED THE CHARACTERISTICS AS "SUBCUTANEOUS FAT WAS FIRM AT UPPER AND LOWER ABDOMEN" AND "ENLARGED AT UPPER AND LOWER ABDOMEN ABOVE AND LATERAL TO UMBILICUS" 4 MONTHS POST TREATMENT.

  Patient problems: Hyperplasia

  MAUDE report 24887971 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT A PATIENT RECEIVED A COOLSCULPTING ELITE TREATMENT TO THE ANDOMEN AND FLANKS USING THE CURVE 150 APPLICATOR AND PRESENTED WITH PARADOXICAL HYPERPLASIA 7 MONTHS POST TREATMENT.

  Patient problems: Hyperplasia

  MAUDE report 24887452 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS TREATED OVER THE FLANKS, ABDOMEN, POSTERIOR BRA, AND INNER THIGHS; WITH THE CURVE 150, FLAT 125, CURVE 240, AND CURVE 120 APPLICATORS ON (B)(6) 2025, (B)(6) 2025, (B)(6) 2025, (B)(6) 2025, (B)(6) 2025, AND (B)(6) 2025, AND PRESENTED WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 24874287 ↗